Kornimate/medical-research-clean huggingface dataset:
the use of etanercept (enbrel®) in the treatment of acute graft-versus-host disease

Conditions: Graft-Versus-Host Disease

Summary: etanercept (enbrel) will be added to standard therapy for acute graft-versus-host disease to see if the effectiveness of standard therapy can be improved. partial funding source- fda oopd

the standard treatment for acute graft-versus-host disease is a combination of steroids and tacrolimus or cyclosporine. previous work has shown that less than 50% of patients respond fully to gvhd. without a good response, patients often have a prolonged treatment for this disease, often involving hospitalization and sometimes even death. etanercept is a drug that blocks a chemical called tumor necrosis factor (tnf) from causing damage to tissue. etanercept (enbrel) will be added to help improve the response to standard treatment for graft-versus-host disease (gvhd). this is an experimental research project. it is not known whether the etanercept will actually improve the body's response to graft-versus-host disease. this treatment is meant to determine if etanercept will improve your response to treatment of gvhd.

Eligibility criteria:
inclusion criteria: * patient may be transplanted with stem cells from any source using either a myeloablative or nonmyeloablative preparative regimen * patient may be any age * patient must have biopsy proven new onset of agvhd; clinical grading must be ii-iv and may occur after stem cell transplant or donor leukocyte infusion (dli). patients may begin etanercept treatment prior to biopsy confirmation of gvhd. acute gvhd will be determined by clinical presentation and not timing from stem cell infusion * patient must be on solumedrol at a dose of 2mg/kg/day of actual body weight for no more than 72 hours prior to the initiation of etanercept * patient must have evidence of neutrophil engraftment with an anc of \> 500 for three consecutive days * pulse ox \> 90% on room air exclusion criteria: * pregnancy or nursing mother * intolerance or allergic reaction to etanercept * previous use of steroids for treatment of acute gvhd * active infection, chronic or localized, not responding to antibiotics, with continued signs of infection (patients with a positive c. difficile test will not be excluded from the study) * condition that might predispose to developing serious infections (i.e. active and uncontrolled diabetes mellitus, sickle cell anemia) * other investigational agents for the treatment or prophylaxis of graft-vs-host disease within the past 2 weeks * serum creatinine \> 2.0mg/dl * patients being treated for acute pulmonary dysfunction (ips) study using etanercept * patients with hypotension believed to be secondary to sepsis syndrome or heart failure requiring \> 1 inotropic agent, or dopamine \>5mcg/kg/minute for blood pressure support * evidence of congestive heart failure on clinical exam * evidence of hepatic dysfunction with an alt or ast \> 2.5 x uln, not due to gvhd
plasma levels of mk0633 in children ages 6-12 (0633-023)

Conditions: Asthma

Summary: to evaluate the safety, tolerability and plasma levels of single oral doses of mk0633 in pediatric asthma patients ages 6 to less than 12 years.


Eligibility criteria:
inclusion criteria: * patient has mild to moderate asthma * patient is able to swallow pills * patient is able to have have blood draws exclusion criteria: * patient has required a visit to the hospital or emergency room due to an asthmatic event in the last 3 months * patient has an upper respiratory tract infection (uri) * patient has a history of stroke * patient consumes more than 4 caffeinated beverages per day
systolic pressure efficacy and safety trial of alagebrium (spectra)

Conditions: Hypertension

Summary: this study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. the combined total duration of patient participation is approximately 17-20 weeks. four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).


Eligibility criteria:
inclusion criteria: * men or women at least 45 years of age with uncontrolled systolic hypertension measured by office cuff and by an ambulatory blood pressure monitoring device * willingness to be taken off any current antihypertensive treatment to be placed on hydrochlorothiazide in combination with study medication. exclusion criteria: * any significant history, systemic illnesses, or medical condition(s) that could lead to difficulty complying with the protocol or that could confound interpretation of the data.

Keywords: antihypertensive agents/therapeutic use hypertension/drug therapy blood pressure
bacterial ano-rectitis sexually transmitted in a specialized consultation center

Conditions: Ano-Rectal Infection Bacterial Nos

Summary: infectious ano-rectitis is poorly described. their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects. analysis of data from this large population of patients referred to the proctology center for suspicion of neisseria gonorrhoeae and / or chlamydia trachomatis ano-rectitis will help identify risk factors and target prevention strategies and optimized therapeutic management.


Eligibility criteria:
inclusion criteria: * patient over the age of 18 * patient consulting or hospitalized in the proctology center * patient for whom an anorectal sampling will be performed for suspicion of sexually transmitted infectious ano-rectitis exclusion criteria: * patient's opposition to participate * patient deprived of liberty * patient under guardianship
gram stain-guided antibiotics choice for ventilator-associated pneumonia (grace-vap) trial

Conditions: Ventilator Associated Pneumonia

Summary: background: optimising the use of antibiotic agents is a pressing challenge to overcoming the rapid emergence and spread of multidrug-resistant pathogens in intensive care units (icus). although gram staining may possibly provide immediate information for predicting pathogenic bacteria, gram stain-guided initial antibiotic treatment is not well established in the icu setting. the investigators planned the gram stain-guided antibiotics choice for ventilator-associated pneumonia (grace-vap) trial to investigate whether gram staining can safely restrict the use of broad-spectrum antibiotics in patients with ventilator-associated pneumonia (vap), which is one of the most common hospital-acquired infections in icus. methods/design: the grace-vap trial is a multicenter, randomised, open-label parallel-group trial to assess the non-inferiority of gram stain-guided initial antibiotic treatment to guidelines-based initial antibiotic treatment for the primary endpoint of clinical cure rate in patients with vap. secondary endpoints include the coverage rates of initial antibiotic therapies, the selected rates of anti-pseudomonal agents and anti-methicillin-resistant staphylococcus aureus (mrsa) agents as initial antibiotic therapies, 28-day all-cause mortality, icu-free days, ventilator-free days, and adverse events. participants are randomly assigned to receive gram stain-guided treatment or guidelines-based treatment at a ratio of 1:1. in the gram stain group, results of gram staining of endotracheal aspirate are used to guide the selection of antibiotics. in the guidelines group, the combination of an anti-pseudomonal agent and anti-mrsa agent are administered. a total sample size of 200 was estimated to provide a power of 80% with a 1-sided alpha level of 2.5% and a non-inferiority margin of 20%, considering 10% non-evaluable participants. discussion: the grace-vap trial is expected reveal whether gram staining can reduce the use of broad-spectrum antibiotics without impairing patient outcomes and thereby provide evidence for an antibiotics selection strategy in patients with vap.


Eligibility criteria:
inclusion criteria: * patients undergoing mechanical ventilation in the icu * patients undergoing mechanical ventilation for at least 48 hours * patients diagnosed as having vap, which is defined by a modified clinical pulmonary infection score of 5 or more exclusion criteria: * patients having an allergy to study medications * pregnant patients * patients discharged from icu * patients diagnosed as having heart failure or atelectasis * patients administered antibiotics for more than 24 hours when they meet the inclusion criteria * patients declined to provide full life support * patients judged as inappropriate at the discretion of the study physician.

Keywords: gram staining antimicrobial therapy empirical therapy nosocomial infection mechanical ventilation intensive care sepsis
a study before/after the implementation of an anti-infectious prescription aid

Conditions: Sepsis; Septic Shock

Summary: anti-infective strategy is a major public health problem. this is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.


Eligibility criteria:
inclusion criteria: * major patients * sepsis or septic shock * oral consent exclusion criteria: * minor patients * death before antibiotherapy * care limitations * pre-hospital antibiotherapy

Keywords: adult patients probabilistic antibiotic therapy to be initiated
neuromodulation for hypothalamic obesity

Conditions: Craniopharyngioma; Hypothalamic Obesity; Metabolic Syndrome

Summary: the balance between hunger and satiety is imperative for an individual's survival and overall health.). without this balance, individuals can become morbidly obese or lack adequate nutrition for survival. craniopharyngioma (cp) is a benign tumour that occurs at the base of the brain in children. unfortunately, pediatric neurosurgeons sometimes inadvertently destroy a child's satiety centre during cp tumour removal surgery. this leaves the child with a post-operative complication: an insatiable appetite. this form of obesity is called "hypothalamic obesity". this study is designed to investigate deep brain stimulation for hypothalamic obesity in n=6 young adults who have stabilized tumours.

for young adults with destroyed satiety centres due to childhood cp surgery, we believe directly re-balancing the brain's control of hunger and satiety is necessary for sustained and long-term therapy. n=6 patients will be recruited in this phase 1 dbs trial. the proposed research will hope to improve personal health among the young adults involved in this study by improving quality of life and avoiding long-term cardiovascular morbidities. furthermore, this study will elucidate what brain regions drive excessive hunger and develop a treatment that attempts to reverse these abnormalities.

Eligibility criteria:
inclusion criteria: * diagnosed with hypothalamic obesity following craniopharyngioma tumour removal * treatment refractory to pharmacological interventions such as growth hormone therapy and anti-obesity medications exclusion criteria: * unable to give consent or unmanaged psychiatric condition
visual perceptual learning based digital therapeutics for stereopsis in intermittent exotropia

Conditions: Intermittent Exotropia

Summary: this study evaluates the efficacy and safety of visual perceptual learning for improving stereopsis in intermittent exotropia. half of participants will receive visual perceptual training using the nu.t. the other half will not receive any training because there is no standard treatment for decreased stereopsis in intermittent exotropia.


Eligibility criteria:
inclusion criteria: * intermittent exotropia patients aged 6 to 15 * patients with decreased stereopsis above 50 arc seconds in titmus dot test * able to use the virtual reality(vr) device * patient or legally authorized representative has signed the informed consent form exclusion criteria: * incomitant strabismus patient with impaired eye movement * patients with amblyopia (maximal corrective vision of one eye is less than 0.8 or maximal corrective vision both eyes more than two lines of difference) * history of ophthalmic surgery * patient who has undergone or is currently undergoing cover treatment within one month for the purpose of treating strabismus or amblyopia * scheduled for ophthalmic surgery during the clinical trial participation period (8 weeks in the treatment group as of the registration date, maximum 16 weeks in the control group as of the registration date) * difficult to understand and perform the stereopsis test. * abnormal retinal correspondence * patient with neurological abnormalities other than strabismus * history of premature birth * participating in other clinical trial * any other condition that, in the opinion of the investigator, precludes participation in the trial
erbium-doped yttrium aluminium garnet laser(er:yag)associated with amorolfine lacquer in the treatment of onychomycosis

Conditions: Onychomycosis

Summary: the study aims to investigate the effectiveness of a single application of er:yag laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. this clinical trial respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a kind of onychomycosis that does not affect the ungual matrix). the patients will receive treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment by means of the clearance of nail plate infection.

this is a trial study involving 30 subjects with onychomycosis of hands or feet. the patient must have at least 2 injured nails as each affected nail will receive a different treatment - self-controlled study design. therefore, each nail out of two from a single patient will be randomized into the following study arms: group a of nails - will receive only weekly application of amorolfine lacquer for a total of 6 months. group b of nails - will receive a single application of er:yag laser followed by weekly application of amorolfine lacquer for a total of 6 months. at the end of 6 months the data from both groups, a and b, regarding \*clinical cure, \*mycological cure and \*extent of damage to the nail plates will be analyzed using specific tests.

Eligibility criteria:
inclusion criteria: * 19-60 year-old * preserved cognitive status * direct mycological examination or culture showing infection of hands or feet nails by dermatophyte molds exclusion criteria: * diabetes type 1 or 2; peripheral vascular disease * having undergone any treatment in the last 6 months * peripheral nerve disorders (e.g. peripheral neuropathy, hansen's disease, etc) * willing to paint nail during the study * high blood pressure * use of any immunosuppressive drugs; congenital or acquired immunodeficiency

Keywords: erbium-doped yttrium aluminium garnet laser er:yag amorolfine lacquer dermatophytes subungual distal lateral onychomycosis drug delivery
efficacy of ivermectin in covid-19

Conditions: COVID

Summary: it is a randomized controlled trial to assess the efficacy of ivermectin in covid-19. patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. out come will be recorded by documenting pcr reports at 48, 96 and 144 hours.

intervention it will be a randomized controlled trial which will be done on covid-19 patients proven by pcr fulfilling the criteria (asymptomatic/mild to moderate severity). they will be divided into two groups after randomization. group a will be administered ivermectin single dose of 12grams along with chloroquine as per existing hospital guidelines and group b will be given chloroquine alone. dose of ivermectin to be repeated at 1 week if pcr stays negative. pcr will be done on alternate days (48, 96 and 144hours) and the duration at which the pcr becomes negative will be compared. dose of drug subject to change in accordance with patient response or possible side effect. eligibility criteria inclusion criteria in order to be eligible to participate in this study, an individual must meet all of the following criteria: provision of signed and dated informed consent form stated willingness to comply with all study procedures and availability for the duration of the study male or female, aged 15 to 65 years in good general health with no or mild symptoms of corona virus disease pcr positive for sars-cov-2. ability to take oral medication and be willing to adhere to the drug intake regimen exclusion criteria an individual who meets any of the following criteria will be excluded from participation in this study: severe symptoms likely attributed to cytokine release storm. malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with cpt class b or c.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged 15 to 65 years * in good general health with no or mild to moderate symptoms of corona virus disease * pcr positive for sars-cov-2. * ability to take oral medication and be willing to adhere to the drug intake regimen exclusion criteria: * severe symptoms likely attributed to cytokine release storm. * malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with cpt class b or c.
topiramate-phentermine combinations for cocaine dependence

Conditions: Cocaine Use Disorder

Summary: this study will determine the influence of topiramate (topamax®) and phentermine (adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.


Eligibility criteria:
inclusion criteria: * recent cocaine use by the intranasal or intravenous route exclusion criteria: * abnormal screening outcome (e.g., ecg, blood chemistry result) that study physicians deem clinically significant * current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion * history of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation * females not currently using effective birth control * contraindications to cocaine, topiramate or phentermine

Keywords: cocaine pharmacotherapy phentermine topiramate self-administration
randomized-controlled trial of aftercare-coordination by phone for depression and anxiety

Conditions: Depression, Anxiety

Summary: the primary objective of this study is to test in a randomized controlled trial if aftercare-coordination by phone subsequent to inpatient treatment is an effective aftercare approach in the treatment of depression and anxiety.

depression and anxiety are among the most prevalent mental health problems and are associated with a high risk of chronification. despite the large capacities in the german health care system only a small percentage of these patients receive treatment. relevant barriers on the pathways of patients are communication und coordination difficulties between different services and providers.the aftercare subsequent to an inpatient treatment represents one of these interfaces. here the aim is to consolidate the treatment outcomes and to minimize the so called rebound-effect, the reduction of the positive treatment effects after the inpatient treatment. although evidence-based treatments for depression and anxiety disorders exist, treatment effects often decrease after treatment due to the lack of an integration of different steps in care. the method of a case management-based aftercare coordination by phone could be a promising approach to overcome the interface between inpatient treatment and aftercare: case management is a patient-centered and situation-based approach which comprises systematic tracking and support of patients by a case-manager. primary goal is to coordinate and integrate services across treatment settings. this approach can help to maintain and even improve longterm treatment outcomes.

Eligibility criteria:
inclusion criteria: * depressive disorder (f32.x; f33.x; f34.1) and/or anxiety disorder (f40.0; f40.1, f41.0; f41.1) according to icd-10 exclusion criteria: * concurrent outpatient psychotherapeutic treatment which will be continued after the inpatient rehabilitation treatment. * no knowledge of the german language * risk of suicide * acute psychosis or psychotic symptoms
walking and thinking - brain activity during complex walking in aging and parkinson's disease

Conditions: Parkinson Disease; Gait Disorders, Neurologic; Aging

Summary: every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. however, the process of aging or the sequelae of neurological diseases such as parkinson's disease (pd) compromises motor-cognitive interaction necessary for an independent lifestyle. while motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions. the challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecological valid state. the investigators aim therefore to explore brain function during complex walking in healthy and pd by investigating the effects of age and neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fnirs) and advanced gait analysis in real time in young, older healthy adults and people with pd.


Eligibility criteria:
healthy young: inclusion criteria: -18 to 50 years exclusion criteria: * disease or condition that affects cognition, gait or balance. * severe hearing or visual impairments that affects participation in the assessments healthy elderly: inclusion criteria: * ≥60 years of age, * 23 or more on the montreal cognitive assessment (moca) exclusion criteria: * disease or condition that affects gait or balance. * severe hearing or visual impairments that affects participation in the assessments parkinson cohort: inclusion criteria: * ≥60 years of age * a clinical diagnosis of pd≤6 months prior to enrollment * with the ability to walk without a mobility device for ≤5 minutes continuously. exclusion criteria: * people with speech difficulties (e.g. aphasia) * cognitive difficulties affecting the ability to understand and/or follow verbal/written - instructions * severe freezing of gait * severe hearing or visual impairments that affects participation in the assessments * other neurological diseases * other disease that can affect gait or balance.

Keywords: functional near infrared spectrometry gait physical activity